Research

CLINICAL TRIALS

Prostate Cancer

J1408 A phase 2 Study of Bicalutamide Plus Finasteride in Men with MRI Detectable Prostate Nodules Undergoing Active Surveillance


Prevention trial.

Overview:
The primary objective of this study are to determine the negative re-biopsy rate as determined by MRI/TRUS-fusion guided biopsy targeting the dominant nodule site defined by pre-treatment MRI following 90 days of combination bicalutamide plus finasteride. Secondary endpoints include rate of exit from active surveillance at two years, safety, and quality of life.

PI: Ken Pienta


A parmacodynamic pre-surgical study of hedgehog pathway inhibition with LDE225 in men with high-risk localized prostate cancer


Prevention trial.

Overview:
This trial is designed as a randomized two-arm (LDE225/observation) open-label prospective clinical trial in men with localized high-risk priostate cancer undergoing radical-prostatectomy. The investigators propose to determine the effects of LDE225 on neoplastic prostate tissue from men at high risk os systeic disease progression, by comparing pre-surgical core-biopsy pecimens to tumor tissue harvedsted at the time of prostatectomy.

PI: Emmanuel Antonarakis


A study of allogeneic human bone marrow derived mesenchymal stem cells in localized prostate cancer


Prevention trial.

Overview:
The obiective of this study is to determine systemically infused allogenic bone-marrow derived mesenchymal stem cells(MSCs) home to sites of prostae cancer in men with localized adenocarcinoma of the prostate who are planning to undergo a prostatectomy. Secondary objective include safety and looking at changes in Sexual Health Inventory for Men (SHIM) and Expanded Prostate CAncer Index Composite (EPIC) surveys post-prostatectomy.


Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate


Treatment trial.

Eligibility:
Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Male Accepts Healthy Volunteers: No

Overview:
This will be a Phase II study evaluating the effectiveness and toxicity of a regimen of 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens of 2.5 Gy, 2.7 Gy, and 3.0 Gy daily fractions. The total dose is calculated to be iso-effective for late effects to a conventionally fractionated total dose of 81 Gy, which has been shown to be effective and safe in a large prospective Phase II study. If the alpha/beta ratio for prostate is between 1.5-3.0, then this regimen should be at least as effective or more effective for tumor control than 81 Gy given in conventional fractions.

PI: Danny Song, MD

Contact Name: Contact: Shirl DiPasquale, RN
Phone: 410-614-1598
Email: sdipasq1@jhmi.edu


High-Res Ultrasound Trial for Prostate Cancer Detection


Eligibility:
The current trial is open to men without a known diagnosis of prostate cancer who have indications for prostate biopsy (rising PSA, elevated PSA, and/or abnormal digital rectal examination), and involves a consultation and examination, followed by a TRUS-guided prostate biopsy. Pathologic review of the specimens is then done by world class genitourinary pathologists at Johns Hopkins.

Overview:
The study team is hopeful that this new technology will allow for more accurate detection of clinically significant prostate cancers.Far less cumbersome than prostate MRI, high-resolution TRUS imaging of the prostate is done at the same setting as the biopsy, takes less than 15 minutes to perform, and does not involve an intravenous contrast agent. If the data continue to be promising, this new imaging technology may one day become an important part of prostate cancer diagnosis and surveillance.

PI: Dr. Pavlovich

Contact Name: Lynda Mettee, P.A.-C.
Phone: (410) 550-1700
Email: LZIEMSK1@JHMI.EDU


Supplementation Trial of Vitamin E in Prostate Cancer Patients (STEP)


Prevention trial.

Phase 0.

Overview:
Patients will be randomly assigned to take Vitamin E or placebo to determine if Vitamin E can change biological markers that may be important in causing prostate cancer.

PI: Drs. H. Ballentine Carter & HanYao Huang


Kidney Cancer

Erectile Dysfunction

Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy


Eligibility:
Ages Eligible for Study: 40 Years to 70 Years Genders Eligible for Study: Male Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Patients with biopsy proven low/moderate risk prostate cancer (Gleason 3+3=6, 3+4=7, 3+2=5, 2+3=5, cT1c, cT2a, cT2b, PSA less than 10) between ages 40-70 preoperative IIEF (erectile function section) score equal or greater than 20 AUA symptom score less than 10 and no urinary incontinence Exclusion Criteria: Men with neurological disease IIEF score less than 20 high risk prostate cancer (Gleason 4+3=7, 4+4=8, any Gleason 5, cT2c, cT3, PSA > 10) spinal cord injury history of transurethral resection of prostate (TURP) or other prostate ablative procedures history of priapism, pelvic neuropathy, penile skin lesions/ulcers inability to understand and demonstrate device use instructions.

Overview:
Primary Outcome Measures: Recovery of erectile function following radical prostatectomy. [ Time Frame: 12 months post-radical prostatectomy ] [ Designated as safety issue: No ] Patients will visit with investigators. Physical examination will be performed, including genital exam for any signs of penile irritation. Study subjects will complete the IIEF, EPIC urinary and sexual domain, AUA, EHS, EDITS and TSS questionnaires. Penile length will be measured from pubis to corona of the glans penis (dorsally) and recorded in centimeter using a standard wooden ruler. Secondary Outcome Measures: Recovery of continence after radical prostatectomy [ Time Frame: 12 months post-prostatectomy ] [ Designated as safety issue: No ] Patients will visit with investigators. Physical examination will be performed, including genital exam for any signs of penile irritation. Study subjects will complete the IIEF, EPIC urinary and sexual domain, AUA, EHS, EDITS and TSS questionnaires. Penile length will be measured from pubis to corona of the glans penis (dorsally) and recorded in centimeter using a standard wooden ruler.

PI: Arthur L Burnett, MD, MBA

Contact Name: Robert L Segal, MD
Phone: 410-614-0241
Email: rsegal3@jhmi.edu


Assessment of Penile Vibratory Stimulation Using the Viberect in Men With Mild-Moderate and No Erectile Dysfunction


Eligibility:
Ages Eligible for Study: 30 Years to 60 Years Genders Eligible for Study: Male Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria mild-moderate erectile dysfunction-IIEF-EF score 13-25 no erectile dysfunction-IIEF-EF score equal or greater than 25 Exclusion Criteria Men with neurological disease IIEF score less than 13 Spinal cord injury History of priapism Pelvic neuropathy Post-prostatectomy Penile skin lesions or ulcers Inability to understand and demonstrate device use instructions

Overview:
Primary Outcome Measures: To assess daily or on-demand ease of use, and efficacy of the home use of the Viberect device by men with mild to moderate and no erectile dysfunction [ Time Frame: 4 weeks after initiation of intervention ] [ Designated as safety issue: No ] After obtaining informed consent, the subjects will be instructed in the use of the Viberect device, and will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual/erotic thoughts for approximately 7-10 minutes (depending on erectile response) for 3 times a week, one day apart, throughout the four week period. Men can perform the stimulation once daily, as long as each session is more than 24 hours apart. Men will record device use and intercourse attempts after device use in a diary. They will fill out several validated questionnaires on week 4: Erection Hardness Scale (EHS), EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction), TSS questionnaire Secondary Outcome Measures: To assess safety of using Viberect penile stiumulation for the treatment of mild-moderate ED [ Time Frame: 4 weeks after initiation of intervention ] [ Designated as safety issue: Yes ] After obtaining informed consent, the subjects will be instructed in the use of the Viberect device, and will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual/erotic thoughts for approximately 7-10 minutes (depending on erectile response) for 3 times a week, one day apart, throughout the four week period. Men can perform the stimulation once daily, as long as each session is more than 24 hours apart. Men will record device use and intercourse attempts after device use in a diary. They will fill out several validated questionnaires on week 4: Erection Hardness Scale (EHS), EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction), TSS questionnaire

PI: Arthur L Burnett, MD, MBA

Contact Name: Brian Le, MD
Phone: 410-614-0241
Email: ble6@jhmi.edu


Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy


Eligibility:
To be eligible for this study you must: •Be between the ages of 40 and 59 •Have localized prostate cancer •Be scheduled to have a bilateral nerve sparing radical prostatectomy at Johns Hopkins Hospital •Have intact erectile function •Have a sexual partner of at least 6 months

Overview:
This study will evaluate the effectiveness of erythropoietin versus placebo in the recovery of erectile function in patients undergoing bilateral nerve-sparing radical retropubic prostatectomy for prostate cancer. Recent laboratory findings suggest, that erythropoietin may play a role in protection of the cavernous nerves during surgery. Some degree of nerve trauma occurs during bilateral nerve-sparing radical prostatectomy, but for most it is temporary. Erythropoietin will be studied as an investigational drug for enhancement of erectile function postoperatively.

PI: Arthur L. Burnett, M.D.

Contact Name: Irene Trueheart, R.N.
Phone: (443) 287-1011
Email: itruehe1@jhmi.edu


Use of Vaccum Erection Device for "Penile Rehabilitation"


PI: Arthur L. Burnett, M.D.

Contact Name: Irene Trueheart, R.N.
Phone: 443 287 1011
Email: itruehe1@jhmi.edu


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